Pharmaceutical Regulatory Affairs jobs

Qualified Person (QP) (m/f/d) – Solid Oral Dosage
for the site Killorglin, Ireland

Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Our site in Killorglin is a competence center for hard capsules.

Your key responsibilities

• Act as a registered Qualified Person on the site license, legally certifying and releasing solid oral dosage form bulk batches in accordance with EU GMP directives and HPRA regulations.
• Drive, maintain, and continuously improve site Quality Systems, including Change Control, Deviations, CAPA, Quality Risk Management (QRM), and Out of Specification (OOS) investigations.
• Ensure all manufacturing, packaging, and testing operations strictly align with the Marketing Authorization (MA) and Good Manufacturing Practice guidelines.
• Review and approve batch records and quality documentation to ensure regulatory compliance prior to release.
• Lead root-cause analysis and risk assessments for quality issues and batch-related investigations.
• Partner effectively with site operations, Quality Control, Supply Chain, and Regulatory Affairs to maintain high-quality standards and operational compliance.
• Participate actively in regulatory authority inspections and customer quality audits.

Your profile

• An accredited university degree in Pharmacy or a science degree in combination with a specialized, regulatory-approved postgraduate course
• 2+ years of industrial experience as a Qualified Person (QP) within a pharmaceutical manufacturing environment.
• Proven background in solid oral dosage manufacturing, batch release, and Quality Management Systems (QMS).
• Strong expertise in managing core Quality Systems processes (e.g., CAPA, Deviations, Change Control, Risk Assessment).
• Ability to work on-site in Killorglin to support site quality oversight and cross-functional teams.
• Leadership potential with genuine interest and ambition to progress into senior quality management and site leadership roles.
• High degree of accountability, ethical judgment, and decisive decision-making capabilities.
• Excellent written and verbal communication skills in English.

Your motivation

Are you looking for new challenges in a highly competitive environment? And you want to tackle them creatively and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal conversation!

If you have any questions, I - Lukas Rödder / Human Resources - will be happy to help you: +49 151 16260074

Temmler Ireland Limited • Member of the Aenova Group • Killorglin • County Kerry • Ireland • V93 H972